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Clinical Trials in the UK / NCT07416526
Recruiting Phase 3

A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A

NCT07416526 · tracked via the Priya Life Science UK tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 3
Started
2026-05-15
Last updated
2026-09-09

Condition(s) studied

Hemophilia A

Investigational drug(s) / intervention(s)

NXT007Human Coagulation Factor VIII

NXT007: NXT007 will be administered subcutaneously (SC) using an integrated drug-device combination product.

Human Coagulation Factor VIII: Factor VIII (FVIII) prophylaxis standard of care (SOC) will be administered at the dose and frequency as stated in the local labels and per local country practice.

Study summary

The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of NXT007 prophylaxis compared with Factor VIII (FVIII) prophylaxis in participants with severe or moderate congenital hemophilia A without FVIII inhibitors. The study will include people aged ≥12 years old who have been on FVIII prophylaxis treatment prior to study entry.

Eligibility

Sex
ALL
Min age
12 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Diagnosis of severe (FVIII:C \<1 IU/dL \[International Unit per decilitre\]) or moderate (FVIII:C between ≥1 IU/dL and ≤5 IU/dL) congenital hemophilia A without inhibitors against FVIII * No documented inhibitor (i.e., \<0.6 BU/mL \[Bethesda unit per millilitre\]), FVIII half-life ≥6 hours, or FVIII recovery \>66% in the last 3 years prior to screening * Documented historical negative test for FVIII inhibitor (i.e., \<0.6 BU/mL) within 12 months prior to enrollment * Documentation of the details of prophylactic and episodic FVIII treatment and of the number and type of bleeding episodes for at least the last 6 months prior to screening * Agreement to adhere to the contraception requirements (for potential participants with childbearing potential) Exclusion Criteria: * Sensitivity to any of the study investigations, or components thereof, or drug or other allergy that, in the opinion of the investigator, contraindicates participation in the study * Use of systemic immunomodulators (e.g., interferon or rituximab) at the time of enrollment or planned use during the study, except for anti-retroviral therapy to treat HIV * Planned surgery (excluding minor procedures such as non-molar tooth extraction, incision and drainage) during the study * History or presence of an abnormal ECG that is deemed clinically significant, (e.g., complete left bundle branch block, second- or third- degree atrioventricular heart block) or ECG evidence or clinical history of prior myocardial infarction * Refusal to accept plasma-derived and/or blood product transfusion support in an emergency scenario * History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias such as structural heart disease (e.g., severe left ventricular systolic dysfunction, left ventricular hypertrophy), coronary heart disease (symptomatic or with ischemia demonstrated by diagnostic testing)

Primary outcome measure(s)

Trial sites (27)

FacilityCityRegionStatus
University of Colorado Hemophilia and Thrombosis Center Aurora Colorado Recruiting
University of Iowa Hospitals and Clinics Iowa City Iowa Recruiting
Arbesu Hematologia Godoy Cruz Mendoza Province Recruiting
Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP - PPDS Ribeirão Preto São Paulo Recruiting
Rigshospitalet-Blegdamsvej 9 Copenhaen Denmark Recruiting
AP-HP - Hôpital Bicêtre Le Kremlin-Bicêtre Val-de-Marne Recruiting
Groupement Hospitalier Est-Hopital Femme Mere enfant/Hospice civils de lyon Bron France Recruiting
Universitätsklinikum Bonn Bonn North Rhine-Westphalia Recruiting
Eszak-Pesti Centrumkorhaz -Honvedkorhaz Budapest Pest County Recruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milan Lombardy Recruiting
IRCCS Istituto Clinico Humanitas Rozzano Lombardy Recruiting
Azienda Ospedaliera Universitaria Careggi Florence Tuscany Recruiting
Nara Medical University Hospital Kashihara-shi Nara Recruiting
Tokyo Medical University Hospital Shinjuku-Ku Tokyo Recruiting
Universitair Medisch Centrum Utrecht Utrecht Netherlands Recruiting
Haemophilia Comprehensive Care Centre Parktown Gauteng Recruiting
Kyung Hee University Hospital at Gangdong Gangdong-gu Seoul Recruiting
Chonnam National University Hwasun Hospital Hwasun-gun South Korea Recruiting
Hospital Universitario Vall d'Hebron - PPDS Barcelona Spain Recruiting
Hospital Universitario La Paz - PPDS Madrid Spain Recruiting
Hospital Regional Universitario de Malaga ? Hospital General Málaga Spain Recruiting
Hospital Universitario Virgen del Rocio - PPDS Seville Spain Recruiting
Hospital Universitari i Politecnic La Fe de Valencia Valencia Spain Recruiting
Taichung Veterans General Hospital Taichung Taiwan Recruiting
Tri-Service General Hospital Taipei Taiwan Recruiting
The Royal London Hospital London Middlesex Recruiting
University Hospital of Wales Cardiff United Kingdom Recruiting

More Hoffmann-La Roche trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07416526 on ClinicalTrials.gov ↗ ← All trials in the UK